Reprocessed Ultrasonic Focus™ Curved Shears
•
Avoid contact with any and all metal or plastic instruments or objects during instrument activation. Contact with staples,
clips, or other instruments during instrument activation may result in premature blade failure, resulting in generator solid
tone or instrument error.
•
Avoid incidental and prolonged activation against solid surfaces (such as bone), which may result in blade heating
and/or blade failure.
•
Take care to avoid application of pressure between the blade and tissue pad without tissue in between them as this can
result in damage to the instrument. Both conditions may cause a system failure signaled by a continuous beep when
either of the foot pedals or hand controls buttons are depressed.
•
When the instrument blade is activated the blade tip is active and will cut and coagulate tissue. Care must be taken to
avoid unintentional contact between the blade surfaces and surrounding tissues.
•
The instruments Minimum starting power level defaults to power level 3.
•
Verify hemostasis after withdrawing instrument. If bleeding is still observed, employ appropriate techniques to achieve
hemostasis.
•
When using the Reprocessed Ultrasonic Curved Shears on solid organs, use caution. Due to the limited ability of the
shears to grasp large portions of solid organs and occlude vascular structures of this nature, hemostasis may not be
predictable and may require additional measures for coagulation.
•
Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent
biological contamination. Special disposal handling techniques may be needed to prevent biological contamination if
instruments or devices come into contact with bodily fluids.
Directions for Use
The package label is detachable and may be affixed to the medical record of the patient.
Assembly
1.
Inspect the instrument and package before opening. The contents of the package are sterile if the packaging has
not been compromised. If the package is damaged or if it was opened and the instrument was not used, return
the instrument and package to Stryker Sustainability Solutions.
2.
Remove the instrument from the package and place it in a sterile work area using aseptic technique.
3.
Inspect the instrument for overall condition and physical integrity. Do not use the instrument if any damage is
noted. Return the instrument and packaging to Stryker Sustainability Solutions if it is not in acceptable condition
for surgery.
4.
Attach the Blue Grip Assist on the Hand Piece to the instrument by rotating the instrument onto the Hand Piece in
a clock wise rotation as viewed from the distal end of the instrument (finger tight only).
5.
The Blue Torque wrench is used to tighten the instrument onto the Hand Piece. Use the Grip Assist to hold the
Hand Piece and not the instrument handle when applying the Blue Torque Wrench. Turn the Blue Torque Wrench
clockwise while holding the Hand Piece with the Grip Assist until it snaps twice indicative that sufficient torque has
been applied to secure the instrument.
Note:
Do not use any other means than the Torque Wrench and Grip Assist to attach or detach the device from
the Hand Piece.
Note:
Do not hand torque, damage to the Hand Piece may occur.
6.
Carefully remove the Blue Torque Wrench and Blue Grip Assist from the Hand Piece. Do not dispose of the Blue
Torque Wrench and Grip Assist until completion of the procedure as it is used for removal of the instrument from
the Hand Piece following the procedure.
7. Note:
Take care to avoid damage to the blade while sliding the Blue Torque Wrench onto or off the shaft.
8. Note:
Take care to avoid injury from the blade tip while sliding the Blue Torque Wrench onto or off of the shaft.
Operation
Refer to the Harmonic™ Generator 300 Operator’s Manual (GEN04) for Hand Piece attachment and system
operations instructions.
1.
Before beginning the procedure, verify compatibility of all instruments and accessories.
2.
The generator power may be turned ON after the assembled Hand Piece and Instrument have been connected to
the generator.
a.
Note:
Ensure the Hand Piece and instrument are connected to the generator before turning on the power.
3.
Select the desired MIN power level using the INCREASE and DECREASE buttons on the generator.
a.
Note:
MIN power is defaulted at power level 3.
4.
Higher generator power level is warranted for greater tissue cutting speed and for greater coagulation use a lower
generator power level. The amount of energy delivered to the tissue and resultant tissue effects are a function of
many factors, including the selected power level, blade characteristics, grip force, tissue tension, tissue type,
pathology, and surgical technique.
